MAUDE Adverse Event Report: SPROTTE; SPINAL NEEDLE

Model Number	021163-29A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event took place in the (b)(6).Currently the available data is poor.As soon as further information is available, an additional report will be sent in to the agency.
Event or Problem Description
Irn#: (b)(4).After normal spinal injection, at the moment of removing the needle from the patient, the needle broke up (hub broke off from the actual needle) i had to pull out part of the needle manually from the patient.No injury sustained.No further action required.
Additional Manufacturer Narrative
Event took place in the (b)(6).Based on risk assessment and clinical evaluation report this failure is estimated to be an isolated individual event.This file is considered as closed.
Event or Problem Description
Irn#: (b)(4).After normal spinal injection, at the moment of removing the needle from the patient, the needle broke up (hub broke off from the actual needle) i had to pull out part of the needle manually from the patient.No injury sustained.No further action required.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE
• MDR Report Key: 11617410
• Report Number: 9611612-2021-00004
• Device Sequence Number: 11518427
• Product Code: BSP
• UDI-Device Identifier: 04048223052679
• UDI-Public: 04048223052679
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: 021163-29A
• Device Catalogue Number: 021163-29A
• Device Lot Number: 1344
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 06/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention